Events

Recall of Device Recall ConForMIS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ConforMIS, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72108
  • Event Risk Class
    Class 2
  • Event Number
    Z-0141-2016
  • Event Initiated Date
    2015-08-31
  • Event Date Posted
    2015-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139892
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    May contain small amounts of ethylene glycol residue.
  • Action
    ConForMIS issued a Press on August 31, 2015 to the general public The sales force was notified through email. The sales personnel for affected accounts that had upcoming surgeries scheduled were asked to confirm that the affected surgeries were cancelled and that the devices were not used in surgery (Formal notification letters will be distributed to the affected accounts by Tuesday, September 8, 2015. The user required to confirm their understanding of the recall and to return any unused product to ConforMIS. Distribution of the letters conducted in two phases as described below: Phase 1-Surgeons with product for which the surgery has not yet been completed Phase 2-Surgeons for whom product was confirmed to have been consumed/implanted. An updated Surgeon letter dated September 8, 2015 issued includes additional information for devices that have been used in surgery. Contact your local ConforMIS representative or Amita Shah, at 17813459164.

Device

Device Recall ConForMIS
  • Model / Serial
    Serial Numbers (US):  0355146 0354541 0355265 0354782 0355485 0355303 0352821 0354413 0353756 0351007 0354577 0354250 0352676 0354571 0353838 0353285 0347734 0354520 0354841 0354148 0353307 0355478 0354830 0353427 0353729 0353683 0353887 0351415 0354255 0354219 0355807 0353995 0352944 0353305 0352331 Serial Numbers (OUS):  0347979 0349420 0351218 0351279 0351682 0351688 0351754 0351856 0352523 0352868 0352918 0353077 0353416 0353745 0353805 0353933 0354141 0354189 0354190 0354267 0354325 0354421 0354427 0354561 0354600 0354646 0354678 0354810 0354850 0355339 0355382 0355385
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed Nationwide and in Germany, Switzerland, and UK.
  • Product Description
    ConForMIS iUni Unicondylar Knee Replacement System- || iUNI G2, Right Medial || Catalog Number:M57220600220 (US) || M5722INT0600220 (OUS)
  • Manufacturer
    ConforMIS, Inc.

Manufacturer

ConforMIS, Inc.
  • Manufacturer Address
    ConforMIS, Inc., 28 Crosby Dr, Bedford MA 01730-1402
  • Manufacturer Parent Company (2017)
    Conformis Inc
  • Source
    USFDA